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What is the difference between research and audit?
Patients expect Healthcare professionals to undertake audit and service evulations as part of quality assurance. These have no, or less than minimal, risk that can also be regulated in ways other than Research Ethics Committee (REC) review.

Research may carry greater risk to good clinical practice and it may generate conflicts of interest for the healthcare professional, hence a different approach to the review. Audit and service evaluations do not warrant mandated REC review. Research does.

The table below differentiates research, audit and service evaluation, but we recognise that judgement on occasions will be needed. 

To help, key discriminants are:

  1. intent - the primary aim of research is to derive new knowledge: audit and service evaluation measure level of care. Research is to find out what we should be doing; audit is to find out if we are doing. Nevertheless, a project may have more than one intent; in such a case, a judgement is needed as to the what the primary aim is
  2. treatment - neither audit nor service evaluation uses a treatment without a firm basis of support in the clinical community
  3. allocation - neither audit nor service evaluation allocated treatment by protocol. It is by decision of clinician and patients
  4. randomisation - if randomisation is used, it is research.

Research, audit and evaulation

Research

Clincial audit

Service evaluation

The attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them

Designed and conducted to produce information to inform delivery of best care

Designed and conducted solely to define or judge current care

Quantitiative research – designed to to test a hypothesis

Qualitative research – identifies / explores themes following established methodology

Designed to answer the question: “Does this service reach a predetermined standard?”

Designed to answer the question:“What standard does this service achieve?”

Addresses clearly defined, questions, aims and objectives

Measures against a standard

Measures current service without reference to a standard

Quantitiative research – may involve evaluating or comparing interventions, particulary new ones

Qualitative research – usually involves studying how interventions and relationships are experienced

Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference)

Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patients preference)

Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations addditional to routine care

Usually involves analysis of existing data but may include administration of simple interviews or questions

Usually involves analysis of existing data but may include administration of simple interviews or questionnaires

Quantitative research – study design may involve allocating patients to intervention groups.

Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justication  

No allocation to intervention groups: the health care professional and patients have chosen intervention before clinical audit

No allocations to intervention groups: the health care professional and patients have chosen intervention before service evaluation

May involve randomisation

No randomisation

No randomisation

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What is a sponsor?
In research the sponsor is an individual, company, institution or organisation which takes responsiblity for the initation, management, and/or financing of a research study.

What do I have to do if a clinical incident happens when I am carrying out research?
You need to complete a clinical incident form and write on the clinical incident form R&D. This will tell the Risk team that the incident occured whilst conducting research.

Further information is available from the Trust incident reporting policy and the R&D policy on reporting clinical incidents in research.

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I have recently had an article published about my research project – do I have to inform R&D?

Yes you need to inform the R&D Office if you have had an article published or you have presented at a national conference.  This information is vital for the annual report that we have to submit to the Department of Health every year. The easiest way of informing the R&D Office is by emailing with the following details

For articles published

  • name of publication
  • title of article
  • authors
  • issue no/date
  • page no

For presentations at conference

  • type of presentation - oral or poster
  • title of presentation
  • name of conference
  • date of conference
  • venue of conference
  • authors/name of people presenting.

How to I set about developing a research project?
All research (including student research) projects involving hospital staff, patients and/or facilities at Homerton Hospital must have gained both Ethics (in most cases) Research and Development Management Approval before the study can start at Homerton.

If you do not have this letter of approval you may not begin a research project – doing so constitutes research misconduct.

The research process involves the following 10 steps

  1. turn your idea into a research question
  2. review the literature
  3. design the study and develop the method(s)
  4. write your research proposal
  5. identify funding
  6. obtain ethical and Trust (R&D) approval
  7. collect and collate the data
  8. analyse the data and interpret the findings
  9. impact of your research on clinical practice
  10. reporting the findings and dissemination of the results.

I need an invoice to be raised to claim money owed for research carried about – who do I contact to organise this?
All requests for invoices to be raised in connection with any research project, must come through Roger Griffith in the R&D Office. This will ensure that you will have one point of contact and she will chase the finance department  if payments are not made.

If you need an invoice  to be raised please email Roger Griffith with the following details:

  • title of research study
  • R&D no
  • who the invoice needs to be sent to with contact
  • details details of the invoice including amount to be claimed.

What does CI and PI mean?
CI stands for Chief Investigator and he/she is the person in charge of the study through England. PI stands for Principal Investigator and he/she is the local investigator at Homerton.

What does GCP stand for?
GCP stands for Good Clinical Practice. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. 

Compliance with this standard provides public insurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and that clinical trials data are credible.